Registration Dossier
Registration Dossier
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EC number: 203-835-0 | CAS number: 111-11-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Relevant methodological deficiencies (purity of test substance is not specified; test substance was only tested in combination with the mutagen busulfan, test dose was only 100 mg/kg bw).
Data source
Reference
- Reference Type:
- publication
- Title:
- The anticlastogenic potential of fatty acid methyl esters.
- Author:
- Renner, H.W.
- Year:
- 1 986
- Bibliographic source:
- Mutat Res 172: 265-269
Materials and methods
- Principles of method if other than guideline:
- The anticlastogenic effects of different methyl esters of fatty acids (C6 - C20) were examined on busulfan in Chinese hamster bone-marrow cells using the chromosome aberration test. Only one dose of 100 mg/kg bw of the test substance was tested and only in combination with the mutagen busulfan.
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Methyl octanoate
- EC Number:
- 203-835-0
- EC Name:
- Methyl octanoate
- Cas Number:
- 111-11-5
- Molecular formula:
- C9H18O2
- IUPAC Name:
- methyl octanoate
- Details on test material:
- - Name of test material (as cited in study report): methyl ester of caprylic acid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: inhouse-bred
- Age at study initiation: 12 - 18 weeks
- Weight at study initiation: 30 - 40 g
- Diet: laboratory chow (Herilan MRH, Eggersmann, Rinteln), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: liquid paraffin
- Justification for choice of solvent/vehicle: the solvent used had to be the same for the fatty acid esters as for the mutagen, to avoid differences in resorption and biological availability
- Amount of vehicle (if gavage or dermal): 0.15 mL/animal (corresponding to 5 mL/kg) - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: the busulfan solution was prepared in an ultrasonic bath
- Duration of treatment / exposure:
- two consecutive treatments (test substance, immediately followed by busulfan)
- Frequency of treatment:
- single treatment
- Post exposure period:
- 30 hours after treatment
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw fatty acid methyl esters
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
50 mg/kg bw busulfan
Basis:
actual ingested
- No. of animals per sex per dose:
- 3
- Control animals:
- other: yes, concurrent no treatment and concurrent vehicle
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- OTHER:
- Colchicine was used at 1 mg/kg and injected subcutaneously 2 h before femora cells were flushed out
- 100 metaphases/animal were evaluated - Statistics:
- t-test was used for comparison of fatty acid methyl ester effects on busulfan induced aberrant metaphases
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- other: the test substnace did not act anticlastogenically
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table1: Examination of the anticlastogenic activity of Fatty Acid Methyl Esters (100 mg/kg p.o.) on Busulfan (50 mg/kg p.o.) induced aberrations
| Number of C-atoms in the acid | Methyl ester of the fatty acid + busulfan | Aberrant metaphases (excluding gaps)% ± SD |
| C8 | caprylic acid | 9.8 ± 0.8 |
| untreated control | without ester an busulfan | 0.4 |
| positive control | only busulfan | 9.4 ± 1.0 |
| control | with solvent (paraffin) | 0.2 |
Applicant's summary and conclusion
- Conclusions:
- The test substance did not show anticlastogenic potential to busulfan induced aberrations.
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